About this role
Job title: Associate Centralized Monitoring Lead
About the Role IQVIA's Associate Centralized Monitoring Lead supports CMS leads on activities related to the CMS team, collaborating with project and clinical leads and other functional teams to deliver on contract objectives while optimizing speed, quality and cost. This role focuses on supporting the centralized monitoring team, evaluating clinical risks and implementing strategies to address issues, and ensuring patient safety and data integrity.
What You'll Do
- Provide support to CMS leads on clinical deliverables per protocol, SOPs, regulations, and COP from applications/analytics/therapeutics/quality perspectives.
- May perform functional lead responsibilities for smaller/less complex projects from start-up to closeout.
- Attend Kick-Off, weekly team, and client meetings; document CMS action items.
- Support CMS Lead in overseeing study finance information and provide inputs to EAC.
- May manage Investigator Payment Activity from setup to closeout.
- Contribute to development of study management plans, risk assessment and mitigation plans, tools and templates to ensure audit readiness.
- Support CMS Lead/project team to develop monitoring strategy, including monitoring triggers/thresholds, analytics strategy; develop analytics proposals on customer demand; perform quality reviews of analytics output; manage operational insight and study/site metrics trend analysis; review COP compliance; provide inputs to decision makers.
What We're Looking For
- Experience supporting CMS teams and clinical monitoring activities; strong collaboration with project teams.
- Understanding of ICH/GCP guidelines, regulatory requirements, SOPs, and quality standards.
- Ability to develop monitoring strategies, risk assessment and mitigation plans, and study analytics.
- Experience with site visits, data integrity, safety reporting, and issue escalation.
- Strong communication, documentation, and problem-solving skills; ability to manage multiple projects.
Nice to Have
- Experience with Investigator Payments and finance aspects in studies; audit readiness.